FDA gives nod to Pfizer's oral cephalosporin for canine skin infections

NEW YORK -Pfizer Animal Health received approval from the Food and Drug Administration (FDA) for Simplecef™ (cefpodoxime proxetil) tablets, the only oral cephalosporin approved to treat canine skin infections (wounds and abscesses) with the ease of once-daily dosing.

The first canine oral cephalosporin therapy of its kind, Simplicef is an extended-spectrum, first-line therapy that provides a number of benefits, the company reports, including safety and efficacy with once-daily dosing that may facilitate improved compliance through convenience for the veterinarian and pet owner.

"Simplicef is an excellent addition to the broad range of canine anti-infectives available from Pfizer," says Malcolm Kram, DVM, associate director, Veterinary Operations for Pfizer. "Its proven once-daily dosage makes it a first-line choice over the other oral cephalosporins."

Compliance issues are an all too common concern in the veterinary community. In fact, 72 percent of veterinarians say that the majority of the time, lack of compliance is the primary cause of antibiotic failure. Canine skin infections treated include those caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus canis, Escherichia coli, Pasteurella multocida and Proteus mirabili. Cephalosporin use for skin infections often requires multiple capsules given two to three times daily for large breeds of dogs. Simplicef offers the convenience of reducing the dosage frequency to one administration per day. Depending on the weight of the dog, in many cases only a single tablet of Simplicef per day will be needed.

"One of the biggest challenges when treating a canine skin infection is entrusting the client to administer several capsules at home, several times a day," explains Candace Sousa, DVM, veterinary dermatology specialist. "With the simple once-daily dosing of Simplicef, I'm confident that it will be easier for clients to comply."

In a clinical field study, 216 dogs with skin infections (wounds or abscesses) were treated with either Simplecef (n=118) once-daily or with a positive control antibiotic (n=98) twice-daily for five to seven days. The results clearly demonstrated the efficacy of the once-daily dosing is comparable to the twice-daily dosing of the positive control antibiotic in treating canine skin infections.

When used according to label directions, the small, film-coated tablet has a half-life ranging from five to six hours, while other oral cephalosporins have a half-life between one to two hours.

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